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Completed

NCT Number: NCT03299816

Five, Plus Nuts and Beans for Kidneys

This Five, Plus Nuts and Beans for Kidneys Study is a single center, randomized controlled trial with 2 parallel arms testing the hypothesis that delivery of nutritional advice to adopt a Dietary Approaches to Stop Hypertension (DASH)-like diet and $30/week worth of fruits, vegetables, nuts and beans tailored to personal choices and availability in neighborhood stores, will reduce kidney damage in African Americans with hypertension and chronic kidney disease.

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Key information

About this study

This study will test the effectiveness of dietary advice delivered by a study coach and assistance with weekly online ordering of $30/week worth of potassium rich foods delivered by a local grocer to a community location for reducing urinary albumin excretion among African Americans with hypertension and chronic kidney disease. Participants will be recruited from primary care clinics in Baltimore, MD.

150 African American adults diagnosed with hypertension and with mild/moderate chronic kidney disease based on the presence of albuminuria will be randomly assigned to one of two arms for 12 months. There are 2 phases of the study. In Phase 1 (months 1-4), one study arm will consist of minimal guidance from the study team and a weekly allowance of $30 dollars to purchase food and drinks of their choosing from a local grocer. During Phase 1, the second arm of the study will receive dietary guidance from the study coach and assistance with ordering and purchasing $30/week worth of high potassium foods from the same local grocer. In Phase 2 (months 5-12) neither study arm will receive a food allowance, however the second arm will receive telephonic visits and dietary advice from the study coach.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Self-identified African American race
  • Age 21 years or older
  • Clinical diagnosis of hypertension and have a urine Albumin-Creatinine Ratio (ACR) of ≥30 mg/g with or without estimated Glomerular Filtration Rate (GFR) 30-59 ml/min/1.73m2.
  • Must be under regular care with their Johns Hopkins Community Physicians (JHCP) or Johns Hopkins Outpatient Center (JHOC) physician (seen within the past 12 months).
  • Must have a systolic blood pressure of <=160 mmHg and a diastolic blood pressure of <=100 mmHg (average of two visits)
  • Be on stable doses of antihypertensive medications for a minimum of two months prior to randomization.

Exclusion criteria

  • Cardiovascular (CV) event within 6 months
  • Chronic disease that might interfere with trial participation (e.g. stage 4 or 5 Chronic Kidney Disease, Estimated Glomerular Filtration Rate <30 ml/min/1.73m2)
  • Unwillingness or inability to adopt a DASH-like diet
  • Consumes over 14 alcoholic drinks per week
  • Poorly controlled diabetes (Hemoglobin A1c >9%).
  • Patients with a serum potassium >4.6 milliequivalent (mEq) /L45
  • Urine ACR ≥ 1,000 mg/g

Treatment and study plan

Coaching DASH group (C-DASH)

Behavioral

Participants assigned to the C-DASH diet advice group will be provided $30/week worth of fruits, vegetables, nuts and beans ordered through the study coach and delivered to a community location to reach a certain goal of potassium intake (months 0-4). During phase 2 of the study (months 5-12), a study coach will continue telephonic contact with the participants to set goals for following a DASH-like diet without the weekly food allowance.

Other names: Coaching DASH diet advice group (C-DASH)

Self-Shopping DASH group (S-DASH)

Behavioral

Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases.

Other names: Self-Shopping DASH diet advice Group (S-DASH)

Primary outcomes

  1. Change in Urinary Albumin Excretion From Baseline to 4 Months

    Time frame: Baseline, 4 months

    Urine samples will be collected for ACR (albumin-to-creatinine ratio).

Secondary outcomes

  1. Change in Systolic Blood Pressure From Baseline to 4 Months

    Time frame: Baseline,4 months

    Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl

  2. Change in Systolic Blood Pressure From Baseline to 12 Months

    Time frame: Baseline, end of study (approximately 12 months)

    Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl

  3. Change in Urinary Albumin Excretion From Baseline to 12 Months

    Time frame: Baseline, end of study (approximately 12 months)

    Urine samples will be collected for ACR (albumin-to-creatinine ratio).

Other outcomes

  1. Change in Urinary Albumin Excretion From Baseline to 1 Month

    Time frame: Baseline, 1 month

    Urine samples will be collected for ACR (albumin-to-creatinine ratio).

  2. Change in Systolic Blood Pressure From Baseline to 1 Month

    Time frame: Baseline, 1 month

    Daytime systolic blood pressure monitoring will be determined using OMRON 907-xl

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)

Registry information

Official study title

Community-Based Dietary Approach for Hypertensive African Americans With Chronic Kidney Disease

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Oct 3, 2017
Registry last updated
Jun 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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